Title:  Senior Executive, Regulatory Affairs

Job Summary

Assist Regulatory Affairs Pharmacist to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare.

Regulatory Affairs

• Assist in timely variation submission via NPRA Quest system for pharmaceutical products. As well as product registration maintenance and document retention.
• Keep abreast of updated regulations in Malaysia
• Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and serve as the official and full time liaison personnel with the government’s regulatory agencies and Ministry of Health.

• Ensure proper documentation of all regulatory applications and communications with clients  & Regulatory Authorities

• Ensure DKSH (M) operations are in compliance with all applicable government laws and regulations.
• Ensure services provided are as agreed in RA agreement with Clients.
• Review promotional material, where DKSH as license holder, to ensure contents are fully supported by the Product Information and literature, and in accordance with the PhAMA Code of Conduct and authority’s guideline.

General Responsibilities

• Pharmacovigilance (PV)

  • Acts as local Pharmacovigilance associate supporting Primary Pharmacovigilance responsible person (RPPV).
  • Liaises with Client PV contact persons for timely reporting of Adverse Drug Events and submitting these reports within the stipulated timelines.
  • Liaises with Client PV contact persons for medical device expedited reporting.
  • Performing periodic literature and NPRA MADRAC/Journal search.
  • Maintain Pharmacovigilance Log, Periodic Safety Updates Report Logs and Product Safety Core Data Sheet
  • Responsible for reconciliation of PV logs with clients

   

  Registered Pharmacist

  • Responsible for supervising the discharge of psychotropic drugs
  • Ensure company’s operations are in compliance with all Ministry of Health’s laws and regulations. Maintenance of the various licenses required to operate DKSH’s warehouse and distribution services.

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
• Demonstrate basic understanding of the Global Harmonized System (GHS)
• Demonstrate good working knowledge, comprehension and applications of local regulations
• Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
• Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
• Demonstrate fluency in local language and ideally in English, both written and spoken

Education

• Minimum Bachelor's Degree in Pharmacy.
• Minimum 1-2 years relevant work experience in similar industry.